Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks
研究概览
简要总结
The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.
The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.
详细描述
Drop-out rates from medical clinics in the first months following linkage to HIV care are as high as 50%, with 31-46% of patients dropping out after the first visit. People Living with HIV (PLWH) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (ART) initiation, reduced ART adherence, unsuppressed viremia, and mortality. Moreover, poor retention means effective ART cannot be leveraged to prevent further HIV transmission. The objective of this study is to conduct a fully powered, randomized controlled trial (RCT) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to enhance retention in HIV care.
The aims of this proposal are: (1) To test, in a 2-arm RCT, the efficacy of the ABBT intervention on retention in care and virologic suppression (primary outcomes); and, ART adherence, disclosure of HIV status, perceived social support, HIV stigmatization (secondary outcomes), relative to an Enhanced-Treatment-as-Usual condition; and, (2) To examine the degree to which retention in HIV care and virologic suppression are mediated by (a) increased HIV acceptance (and decreased HIV experiential avoidance) and (b) increased willingness to disclose HIV status. The sample will consist of 270 HIV patients who are new to care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
- •Able to speak and read English at the level to be able to complete the study procedures
- •Have telephone access.
排除标准
- •1. Cognitively impaired
结局指标
主要结局
Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks
时间窗: 52 weeks
Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period.
Number of Participants Who Met HIV Virologic Suppression
时间窗: 52 weeks
Objective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist. A viral load that measures as "undetectable" (i.e., fewer than 200 copies of HIV per millilitre of blood) will represent virologic suppression, which is a positive indication of HIV health.
次要结局
- The Multidimensional Scale of Perceived Social Support (MSPSS)(52 weeks)
- HIV Stigma Scale (HSS)(52 weeks)
- Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence(52 weeks)
- Brief HIV Disclosure Scale (BHD)(52 weeks)
- The Multidimensional Scale of Perceived Social Support (MSPSS)(52 weeks)
- HIV Stigma Scale (HSS)(52 weeks)